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Biopharma Money on the Move: December 2 – 8

The Pharma Data

RayzeBio is also funneling cash into expanding its HQ in San Diego with plans to further develop internal R&D. . Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. SciNeuro Pharmaceuticals . Headquartered in Shanghai, the company will also have a hub in Philadelphia.

RNA 52
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Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances. To do this, it provides both a probiotic and a prebiotic.

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Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). R&D: Up-front payments related to license and collaboration agreements. (85). Regeneron Pharmaceuticals, Inc. Oncology Program.

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Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Click to Tweet : #BREAKING: The #FDA has approved another treatment option for people living with #HIV. . Global Head, Janssen Research & Development, Johnson & Johnson.

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Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. International revenues increased 40% to $3.6

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Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tezepelumab. XmAb is a registered trademark of Xencor, Inc.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

0910-AI78 June 2023 May 2023 Final Rule Stage Sunlamp Products; Amendment to the Performance Standard FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.